Senior Director, Research Compliance

Overview

Western Michigan University Homer Stryker M.D. School of Medicine is recruiting for a Senior Director, Research Compliance. The Senior Director for Research Compliance provides coordination for the administration, support, and monitoring of regulatory committees and activities including the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC) and the Institutional Biosafety Committee (IBC). The Senior Director for Research Compliance has the responsibility to oversee the administration of policies and regulations mandated by federal and state law in the areas of human subject’s protection, animal welfare regulations, radiation safety, biosafety, research conflict of interest and controlled substances in research.  The position oversees the overall operations of Sponsored Programs Administration which includes proposal development, budget creation, grant management and compliance.

 

The Senior Director for Research Compliance demonstrates the highest level of personal and professional commitment, enthusiasm, integrity, and support of the medical school and its mission, vision, and values; aligns with and supports all aspects of the medical school; and strives to achieve excellence in all aspects of operations.

Responsibilities

• Directs and oversees the administration of research compliance services and programs, including human research protections, conflict of interest, Institutional Review Board (IRB), Institutional Animal Use and Care Committee (IACUC), Institutional Biosafety Committee, Radiation Safety, Export Control and other committees as identified.
• Serves as signing official for research agreements including grant submissions, grant agreements and material transfer agreements as delegated by senior leadership.
• Build and preserve a culture of research compliance at WMed.
• Maintain the continuous quality improvement and post monitoring activities within the department of research compliance.
• Oversees the management of research compliance staff in their efforts to secure and maintain Association for the Accreditation of Human Research Protection Program (AAHRPP) and Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).
• Serves as the primary point of contact for internal and external groups and organizations related to research compliance.
• Acts as the Clinical Laboratory Improvement Amendments (CLIA) for sponsored research at WMed.
• Provide strong leadership in identifying, developing relations with, and securing extramural support from appropriate governmental agencies, private foundations, and business and industry in support of WMed research programs.
• Coordinate the dissemination of information related to federal, state, and private sector support and opportunities for grant funding.
• Assist IT staff in the development and deployment of effective electronic research administration systems. Promote the effective and efficient utilization of electronic systems for grant proposal submission.
• Foster internal and external communication regarding the research activities of the institution and promote the medical school to its various public and private constituencies in research and scholarly activities.
• Oversee the implementation of policies regarding patents, copyrights, and intellectual property rights in research agreements with private sponsors, as well as in faculty/staff interests related to these matters.
• Availability to work occasional overtime on weekends or evenings to complete time sensitive projects.
• Acquires knowledge for new technology and policy/procedure revisions.
• All other duties as assigned.

Qualifications

EDUCATION AND/OR EXPERIENCE:

• Master’s degree in a relevant field from an accredited institution.  Terminal degree preferred.  
• Minimum of 10 years’ experience with progressively responsible experience in a leadership position in sponsored research administration in a university or medical center required.
• Proven success in directing the work of a large staff and providing effective management of external funding.
• Experience in grant proposal development and post award management.
• Knowledge and practical application of regulations related to USDA, FDA, Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) and other relevant guidelines.

 

LICENSES, REGISTRATIONS, CERTIFICATIONS:

• Current NIH or Citi training.

 

OTHER SKILLS AND ABILITIES:

• Strong critical thinking skills and the ability to analyze summarize and effectively present data.
• Exceptional interpersonal skills and the ability to interact effectively with academic leadership, faculty